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8.3 conception and development ISO 9001:2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by hopech, Dec 24, 2020.

  1. hopech

    hopech Member

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    Hello everyone
    I need your point of view about this paragraph

    I wonder if the paragraph of design and development applies if the plans are taken from a catalog of automotive spare parts i.e. everything is defined does it make sense to apply the requirements of paragraph 8.3 and what does apply exactly
    Thank you for your help
    Best regards
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @hopech ;
    It is up to your organization to determine the scope of your management system and per clause 4.3...

    "...and provide
    justification for any requirement of this International Standard that the organization determines is not
    applicable to the scope of its quality management system."


    If the DESIGN of the products (and/or services) that your organization provides is NOT the responsibility of your organization, then section clause 8.3 does not apply. Simply state something similar in your scope. (e.g. "Design of the products we provide is not the responsibility of our organization and is controlled by our customers, therefore, the scope of our QMS excludes clause 8.3")

    Hope this helps.

    Be well.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can you give us a concrete example? I can see cases for application of 8.3 and for avoiding it! Let's understand more about what the organization does!
     
  4. hopech

    hopech Member

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    Hello Jhon, Andy,
    thanks for replying!
    the problem is that the design of our products is not controlled by our customers that's why im confused
    at the same time we're just manufacturing parts with defined specifications (automotive spare parts)

    so can i exclude this paragraph
     
    Last edited: Dec 25, 2020
  5. hopech

    hopech Member

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    for example mitsubishi spare parts, citroen and many others
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Who approves a design change?
    This doesn't really help much. A shock absorber can be a spare part, but the design is (usually) owned by the manufacturer (like Bilstein). You'll have to tell us whether your organization can change a design without others' approvals or if some other org. owns that right.
     
  7. hopech

    hopech Member

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    Hello Andy,
    no we can't change the design we are just manufacturing mechanical parts according to the specifications of original ones
    what should i apply in this case
    should i have approved design plans
    i'm pretty confused
    thank you for your help i appreciate it
     
  8. tony s

    tony s Well-Known Member

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    Are these specifications provided by your customers?
     
  9. hopech

    hopech Member

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    Hello tony s
    thank you for your interest
    no not by our customers it's the car/truck manufacturers specifications
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Firstly, it's not simply a case of not including design in the scope. If you only manufacture to others specifications, it's clear. You are not design responsible. You don't (naturally) have a product design process, either. It all comes from understanding the Context of the organization, your interested parties needs and expectations etc. You can simply work this answer out yourself - and your leadership should be guided through the process, as the ISO 9001 requirements expect you to do.

    If you simply ask us and go away not knowing how each requirement of the standard points the way to deciding in what is "in' your scope and, hence your QMS, then you will have gained nothing.
     
  11. hopech

    hopech Member

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    Hello Andy,
    I know but I'm wondering how to demonstrate that we are not design responsible if this is not controlled by our customers
    in other words, who is responsible
    it's just an imitation of the originals parts
    what can proove that the specifications are reliable this is my question
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I believe you are over thinking this. You can't change the design. That's all that matters.
     
  13. hopech

    hopech Member

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    Hello Andy,
    Happy new year ,best whishes
    sorry for the unexpected delay
    i have a concrete example
    we are imitating a model part given by the client
    we are just measuring its dimensions to draw our manufacturing plan which will be displayed in the plant
    in this case what does apply ?
    thank you for helping me out I appreciate it
    [​IMG]
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You are not design responsible. You are a service provider of what's commonly known as "reverse engineering". You don't have a product which you own the specification to. Don't include design in your scope or QMS as a process.
     
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  15. hopech

    hopech Member

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    thank you so much Andy
     
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  16. hopech

    hopech Member

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    yes Andy we are just measuring dimensions and devlopping the mold design to obtain the same customer's part
     
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